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Long-term effectiveness of enzyme replacement therapy in Fabry disease: results from the NCS-LSD cohort study.
[fabry disease]
To
determine
the
effectiveness
of
enzyme
replacement
therapy
(
ERT
)
for
adults
and
children
with
Fabry
disease
.
Cohort
study
including
prospective
and
retrospective
clinical
data
.
Age-
and
gender-adjusted
treatment
effects
were
estimated
using
generalised
linear
mixed
models
.
Treated
patients
contributed
data
before
and
during
treatment
and
untreated
patients
contributed
natural
history
data
.
Consenting
adults
(
N
 
=
 
289
)
and
children
(
N
 
=
 
22
)
with
a
confirmed
diagnosis
of
Fabry
disease
attending
a
specialist
Lysosomal
Storage
Disorder
treatment
centre
in
England
.
At
recruitment
211
adults
and
seven
children
were
on
ERT
(
range
of
treatment
duration
,
0
to
9
.
7
and
0
to
4
.
2
Â
years
respectively
)
.
Clinical
outcomes
chosen
to
reflect
disease
progression
included
left
ventricular
mass
index
(
LVMI
)
;
proteinuria
;
estimated
glomerular
filtration
rate
(
eGFR
)
;
pain
;
hearing
and
transient
ischaemic
attacks
(
TIA
)
/
stroke
.
We
found
evidence
of
a
statistically
significant
association
between
time
on
ERT
and
a
small
linear
decrease
in
LVMI
(
p
 
=
 
0
.
01
)
;
a
reduction
in
the
risk
of
proteinuria
after
adjusting
for
angiotensin-converting
enzyme
inhibitors
and
angiotensin
receptor
blockers
(
p
 
<
 
0
.
001
)
and
a
small
increase
in
eGFR
in
men
and
women
without
pre-treatment
proteinuria
(
p
 
=
 
0
.
01
and
p
 
<
 
0
.
001
respectively
)
.
The
same
analyses
in
children
provided
no
statistically
significant
results
.
No
associations
between
time
on
ERT
and
pain
,
risk
of
needing
a
hearing
aid
,
or
risk
of
stroke
or
TIAs
,
were
found
.
These
data
provide
some
further
evidence
on
the
long
-term
effectiveness
of
ERT
in
adults
with
Fabry
disease
,
but
evidence
of
effectiveness
could
not
be
demonstrated
in
children
.
Diseases
Validation
Diseases presenting
"statistically significant association"
symptom
alpha-thalassemia
congenital diaphragmatic hernia
fabry disease
familial mediterranean fever
legionellosis
locked-in syndrome
oral submucous fibrosis
trochlear dysplasia
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